buprenorphine hcl

Generic: buprenorphine hcl

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine hcl
Generic Name buprenorphine hcl
Labeler specgx llc
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 8 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-7018
Product ID 0406-7018_12e82887-be89-46cd-a55a-46e9e2ef2cba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218473
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2026-01-19

Pharmacologic Class

Classes
partial opioid agonist [epc] partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04067018
Hyphenated Format 0406-7018

Supplemental Identifiers

RxCUI
351264 351265
UPC
0304067018030 0304067012038
UNII
56W8MW3EN1

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name buprenorphine hcl (source: ndc)
Generic Name buprenorphine hcl (source: ndc)
Application Number ANDA218473 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0406-7018-03)
source: ndc

Packages (1)

0406-7018-03 30 TABLET in 1 BOTTLE (0406-7018-03)

Ingredients (1)

buprenorphine hydrochloride (8 mg/1)

Linked Drug Pages (1)

Buprenorphine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "12e82887-be89-46cd-a55a-46e9e2ef2cba", "openfda": {"upc": ["0304067018030", "0304067012038"], "unii": ["56W8MW3EN1"], "rxcui": ["351264", "351265"], "spl_set_id": ["b60d514d-a88a-4fa2-a5b0-30ac29e04973"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0406-7018-03)", "package_ndc": "0406-7018-03", "marketing_start_date": "20260119"}], "brand_name": "Buprenorphine HCl", "product_id": "0406-7018_12e82887-be89-46cd-a55a-46e9e2ef2cba", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0406-7018", "dea_schedule": "CIII", "generic_name": "Buprenorphine HCl", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine HCl", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA218473", "marketing_category": "ANDA", "marketing_start_date": "20260119", "listing_expiration_date": "20261231"}